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NIH Proposes Free Access For Public to Research Data
  NIH & Other Proposals--3 newspaper articles
By Rick Weiss
Washington Post Staff Writer
Monday, September 6, 2004
The National Institutes of Health has proposed a major policy change that would require all scientists who receive funding from the agency to make the results of their research available to the public for free.
The proposal, posted on the agency's Web site (proposal follows this article below) late Friday and subject to a 60-day public comment period, would mark a significant departure from current practice, in which the scientific journals that publish those results retain control over that information. Subscriptions to those journals can run into the thousands of dollars. Nonsubscribers wishing to get individual articles must typically pay about $30 each -- fees that can quickly add up for someone trying to learn about a newly diagnosed disease in the family.
Although patient advocacy groups and other organizations have been lobbying hard for the proposed shift, the scientific publishing industry and related interests are crying foul. The move could drive some journals out of business, they say, and bankrupt some scientific societies that are dependent on journal profits to fulfill their research and education missions.
Whatever the outcome, both sides agree change is inevitable, given society's rising expectations of easy access to information from the Internet and the enormous interest in health -- a topic that NIH officials say accounts for about 40 percent of all Internet queries.
"The status quo is not an option," NIH Director Elias A. Zerhouni said last week at a meeting on the agency's Bethesda campus.
Pressure to make publicly financed research results more available to the public has been building for years but gained new momentum this summer with report language by the House Appropriations Committee.
"The committee is very concerned that there is insufficient public access to reports and data resulting from NIH-funded research," it read. "This situation . . . is contrary to the best interests of the U.S. taxpayers who paid for this research."
The report called upon NIH to devise a system that would ensure that NIH-funded research results be "freely and continuously available no later than six months after publication."
Although the language was nonbinding -- especially given the lack of similar pressure from the Senate -- it gave the NIH the political backing the agency needed to craft a system it had been leaning toward for more than a year. It brought a quick and panicked response from scientific publishers. If contents of their publications are to be made available for free, they argued, people will stop subscribing. And without journals, who would do the expensive work of selecting, peer-reviewing and editing research results into the clean and scientifically reliable products upon which scientists and the public have come to rely?
"The House has held no hearings and has established no evidentiary record," wrote Patricia S. Schroeder, a former Democratic House member from Colorado and now president and chief executive of the Association of American Publishers. Her recent letter was directed to Sen. Arlen Specter (R-Pa.), who heads the Senate appropriations subcommittee overseeing NIH. "Publishers feel steamrolled."
Other critics raised concerns about costs to citizens. "If the NIH has to increase the size of its grants or make other major expenditures to implement a new, open-access system, taxpayers will end up paying more money for less research," said Roberta E. Arnold of the Radiological Society of North America, which supports its scientific activities in part from its journal profits.
Supporters see things differently. "There's lots of free junk and advertisements for snake oil on the Internet, but people can't get the good research unless they pay for it. That does not seem right," said Richard J. Roberts, a research director at New England Biolabs in Beverly, Mass., and one of 25 Nobel laureates who recently signed a letter supporting a shift to open access.
Many doctors and other health professionals in the nation's smaller communities, where major medical libraries do not exist, could also benefit, he said.
Zerhouni heard those and other arguments in three meetings for scientists, publishers and patient advocates in the past six weeks. Last week he said he had concluded that publishers' estimates of how much such a system would harm them or cost the government were "way out of line" with reality.
Indeed, Zerhouni said, open access might enhance business for many journal-publishing companies and societies. By giving the journals a bigger audience, he said, the scientific impact of those journals would increase. Because a journal's "impact factor" is a big determinant of where scientists submit their work, those with greatest access should be able to attract the best papers.
Although about 60,000 articles are published each year as a result of NIH funding, they make up only about a third of all the biomedical literature appearing in journals.
"Do you really think people are not going to subscribe to a journal because they can read 30 percent of the articles in it for free?" Roberts asked. Besides, he said, many journals offer other features such as news and commentary sections that are available only with a subscription.
The NIH proposal calls for researchers to submit their papers to the agency after they have been accepted for publication and edited by the accepting journal. By placing the responsibility on researchers, the policy avoids the prospect of the NIH trying to tell the journals to share those papers. Articles would not be made public by the NIH for six months -- "a compromise position," Zerhouni said, to give the journals time to profit from the work. After that, they would be available for free on the NIH's Web-based database, PubMed Central.
In an interview Friday, Specter said that because of his concerns about the ramifications of open access, he would not add supportive language to the Senate appropriations bill. But he said that he generally likes the open-access principle and that he hopes a reasonable policy will emerge with public input in the next two months.
Alan I. Leshner, president of the American Association for the Advancement of Science, which publishes the journal Science, said the NIH proposal appeared to address "some of the concerns" of publishers and "appears to be a reasonable compromise." Like some other journals, Science makes its articles freely available 12 months after publication.
Several experts predicted that if the NIH proposal is implemented, other major funders around the world will follow suit, triggering a global open-access revolution.
One person who will be celebrating is Debra Lappin of the Open Access Working Group, which has been lobbying for the change. She told Zerhouni last week that she had been part of a federal study of an experimental AIDS vaccine but had been unable to find out the study's results without paying.
"I paid twice for these results," she said. "I paid with my taxes and I paid with blood. I feel like I'm being asked to pay for a third time. I think that's outrageous."
Notice: Enhanced Public Access to NIH Research Information
Notice Number: NOT-OD-04-064
Key Dates
Release Date: September 3, 2004
Issued by
National Institutes of Health (NIH)

The National Institutes of Health (NIH) is dedicated to improving the health of Americans by conducting and funding biomedical research that will help prevent, detect, treat and reduce the burdens of disease and disability. In order to achieve these goals, it is essential to ensure that scientific information arising from NIH-funded research is available in a timely fashion to other scientists, health care providers, students, teachers, and the many millions of Americans searching the web to obtain credible health-related information. NIH's mission includes a long-standing commitment to share and support public access to the results and accomplishments of the activities that it funds.
Establishing a comprehensive, searchable electronic resource of NIH- funded research results and providing free access to all, is perhaps the most fundamental way to collect and disseminate this information. The NIH must balance this need with the ability of journals and publishers to preserve their critical role in the peer review, editing and scientific quality control process. The economic and business implications of any changes to the current paradigm must be considered as the NIH weighs options to ensure public access to the results of studies funded with public support without compromising the quality of the information being provided. The NIH has established and intends to maintain a dialogue with publishers, investigators, and representatives from scientific associations and the public to ensure the success of this initiative.
This notice is to announce and to seek public comments regarding NIH's plans to facilitate enhanced public access to NIH health related research information. NIH intends to request that its grantees and supported Principal Investigators provide the NIH with electronic copies of all final version manuscripts upon acceptance for publication if the research was supported in whole or in part by NIH funding. This would include all research grants, cooperative agreements, contracts, as well as National Research Service Award (NRSA) fellowships. We define final manuscript as the author's version resulting after all modifications due to the peer review process. Submission of the final manuscript will provide NIH supported investigators with an alternate means by which they will meet and fulfill the requirement of the provision of one copy of each publication in the annual or final progress reports. Submission of the electronic versions of final manuscripts will be monitored as part of the annual grant progress review and close-out process.
NIH considers final manuscripts to be an important record of the research funded by the government and will archive these manuscripts and any appropriate supplementary information in PubMed Central (PMC), NIH's digital repository for biomedical research. Six months after an NIH supported research study's publication—or sooner if the publisher agrees—the manuscript will be made available freely to the public through PMC. If the publisher requests, the author's final version of the publication will be replaced in the PMC archive by the final publisher's copy with an appropriate link to the publisher's electronic database.
As with NIH's DNA sequence and genetics databases, this digital archive in PMC is expected to be fully searchable to enhance retrieval and can be shared with other international digital repositories to maximize archiving and to provide widespread access to this information. It is anticipated that investigators applying for new and competing renewal support from the NIH will utilize this resource by providing links in their applications to their PubMed archived information. This practice will increase the efficiency of the application and review process.
NIH trusts that the up to six month delay to public archiving in PMC recommended by the policy will not result in unreasonable or disproportionate charges to grantees. As with all other costs, NIH expects its grantees to be careful stewards of Federal funds and to carefully manage these resources. We will carefully monitor requested budgets and other costing information and would consider options to ensure that grantees' budgets are not unduly affected by this policy.
The NIH encourages comments concerning its intentions to enhance public access to NIH-funded health related research information as outlined in this notice. Comments on short term impacts and suggestions for mitigating these are especially welcome. We encourage that all comments be directed to the following NIH website: http://grants.nih.gov/grants/guide/public_access/add.htm.
As an alternative, comments may be submitted by email to the following address: PublicAccess@nih.gov
Comments must be received within 60 days of publication of this notice. NIH intends to publish an identical notice in the Federal Register.
Two Articles from NY times on NIH Free Access-Drug Trials Information
Expected Call for Advance Registration of Drug Tests

September 8, 2004
NY Times
The debate over the disclosure of clinical drug trials could reach a turning point this week, with editors of influential medical journals expected to call for fundamental changes in the way such tests are reported.
The journal editors, gatekeepers for the medical profession, are expected to begin requiring that drug trials be registered at the outset as a prerequisite for the subsequent publication of their results. Requiring such registration as a condition for reaching the journals' vast audience of doctors would make it difficult for drug companies to hide the results of unflattering tests - as some have been accused of doing.
The journal editors declined yesterday to discuss the new policy before the announcement, but the group said several months ago that it was considering such a step.
Details of the policy by the group - which includes prestigious publications like The Journal of the American Medical Association, The New England Journal of Medicine, The Lancet and The Annals of Internal Medicine - are to be presented Thursday at a House Commerce subcommittee hearing on disclosure of data from pediatric trials of antidepressants.
Meanwhile, both House and Senate Democrats say they expect to introduce legislation as early as Thursday that would require drug trials involving human subjects to be registered in a public database before the tests were allowed to proceed.
Congressional Republicans, though, have not announced any plans for such legislation. And an official of the drug industry's trade group, which yesterday announced a voluntary plan to disclose trial results, said his organization thought that legislation was not necessary.
Some academic researchers have long argued that drug companies unduly influence medical practice by highlighting positive trial findings while not publishing negative ones. The subject gained public prominence earlier this year with the disclosure that unpublished test data from trials of some widely used antidepressants had indicated that some adolescents and children who took the drugs had a greater tendency toward suicidal thoughts than those given placebos.
"People have been concerned for quite some time that nondisclosure of unfavorable studies has skewed the scientific literature and possibly medical practice," said Dr. Ronald M. Davis, a trustee of the American Medical Association. "But recently, tangible evidence of that concern has arisen."
Makers of antidepressants have denied concealing any data. But in recent months, they and other drug producers have scrambled to address criticism about disclosure in the industry of trial results.
Three leading companies, GlaxoSmithKline, Eli Lilly and Merck have recently announced plans under which they would provide more public information about their drug tests and the results. Yesterday, the industry trade association, the Pharmaceutical Research and Manufacturers of America, said it was creating a Web site on which its members could voluntarily post the results of trials of their medications.
Also yesterday, the New York State attorney general, Eliot Spitzer, said in a telephone interview that his office had reached an agreement with another drug maker, Forest Laboratories, for it to disclose the results of clinical trials. Mr. Spitzer had sought information from Forest about how it marketed and disclosed test results for its antidepressant Celexa and other drugs, but his office has not begun a formal investigation or accused the company of wrongdoing.
This past spring, Mr. Spitzer sued GlaxoSmithKline, contending that it misled doctors by playing down negative pediatric test information about its popular antidepressant Paxil. And soon thereafter, the American Medical Association called for the federal government to create a database in which drug companies would be required to register clinical tests of their medications at the outset and report the results.
In June, the group from the medical publications, calling itself the International Committee of Medical Journal Editors, said it was considering requiring companies to publicly register tests in order for them to be published later.
Yesterday, two journal editors declined to discuss the details of that plan before its public release on Thursday. But both editors said they supported calls for mandatory drug trial registration and reporting, apparently signaling by their comments that the group planned a major shift in publication policy.
The editors, Dr. Catherine DeAngelis, editor in chief of the Journal of The American Medical Association, and Dr. Jeffrey Drazen, editor of The New England Journal of Medicine, said they believed that the voluntary database announced by the drug industry's trade group was an inadequate solution because it would not specify, among other things, when and how tests would be reported.
"It is self-serving," Dr. Drazen said.
But Dr. Alan Goldhammer, the trade group's vice president for regulatory affairs, rejected such criticism. He said its announcement was intended to enhance doctors' and patients' understanding of valuable medications and how they were tested. The site, which is to begin operating next month, would contain data on trials, whether published or unpublished, dating to late 2002.
"It is going to fulfill the needs of practicing physicians," Dr. Goldhammer added.
Dr. Davis, the A.M.A. trustee, said he believed that the move by the medical journal editors to set new guidelines about drug trial registration would be an important step in helping to ensure consistency in the reporting of test results. Several studies have concluded, for instance, that researchers may not report the primary goal of a drug test if the results are negative or inconclusive but may instead focus on secondary findings that are positive.
He added, though, that the move by the medical editors' group, while an important step, was not a cure-all.
"If you have 10 journals following such a policy but 500 others that are not,'' he said, "then trials that are not registered" may not be disclosed.
For that reason, Dr. Davis said, the A.M.A. was backing legislation that would make the registration of a clinical trial a mandatory part of the trial's receiving approval by so-called institutional review boards. Approval from such groups, known among specialists as I.R.B.'s and typically composed of officials at research universities or other institutions, is required before any medical test can be conducted involving human subjects.
Mandatory reporting of trial results would also be part of such legislation, Dr. Davis said.
"The I.R.B. thing is particularly important," he said, "because you need I.R.B. approval to do a test."
Several Democrats in the Senate and the House are currently developing such a bill. The House version, which is expected to be offered by Representatives Henry A. Waxman of California and Edward J. Markey of Massachusetts, may be introduced as early as Thursday, staff members said.
Drug Industry Site Will Show Trials
Sept 7, 2004
WASHINGTON (AP) -- An association that represents the nation's leading drug manufacturers said Tuesday it has created a Web site where companies can list clinical trials they sponsored for drugs approved by the Food and Drug Administration.
Unlike the FDA's clinicaltrials.gov, the Pharmaceutical Research and Manufacturers of America site will not list trials that are still enrolling patients. Nor will the PhRMA site post details of every clinical trial that companies sponsor, as drug makers GlaxoSmithKline PLC, Merck & Co. and Forest Labs have promised to do.
Beginning Oct. 1, the site will summarize results from selected trials completed since Oct. 1, 2002, on FDA-approved drugs. No details will be listed from clinical trials for drugs that fail to gain FDA approval.
The announcement precedes a congressional hearing that will examine when the industry minimizes trials with negative results. At least seven drug makers are scheduled to testify Thursday at a hearing prompted by the discovery that unpublished data linked antidepressants to suicidal behavior in children.
Caroline Loew, PhRMA vice president for scientific and regulatory affairs, said the group's announcement was ``not a direct response to the congressional environment.'' Loew is among the witnesses scheduled to testify during the House Energy and Commerce subcommittee session.
Dr. Jeffrey Drazen, editor in chief of The New England Journal of Medicine, dismissed PhRMA's proposal as ``too little too late.'' Because PhRMA's registry remains voluntary, drug companies won't feel compelled to include studies that reflect negatively on their products.
Dr. Catherine DeAngelis, editor in chief of The Journal of the American Medical Association, said doctors and patients should have access to all results from medical studies because such data may affect treatment decisions.
The American Medical Association has called for a government-run registry to ensure that consumers and physicians can read details of industry-sponsored trials that question a drug's safety.
Later this week, editors of leading medical journals are expected to announce they will reject papers unless researchers include clinical trials in such a public registry as patients are first enrolled, The Wall Street Journal reported Tuesday.
Alan Goldhammer, PhRMA associate vice president for regulatory affairs, said his group knew about the editors' plans. The group will take a ``hard look'' at the journals' formal announcement, he said, and remains open to suggested improvements.
Still, Goldhammer said, PhRMA remains committed to its own Web site's mission. The PhRMA site aims to help physicians find drug information offered, bit by bit, through conference abstracts, posters and unpublished studies that didn't sufficiently pique the interest of journal editors, he said.
The pharmaceutical industry is facing rising pressure from several sources to become more open in reporting clinical trial results.
Forest Laboratories became on Tuesday the second company to announce it would begin its own Web-based clinical trials registry. New York Attorney General Eliot Spitzer inquired in June about off-label uses of the company's drugs, including Lexapro and Celexa. The New York-based company will post clinical studies involving children's use of those antidepressants on the Web. Forest Labs also will summarize results of all drug trials it sponsored after Jan. 1, 2000, the attorney general's office announced.
And, elsewhere in Congress, Sens. Chris Dodd, D-Conn., and Edward M. Kennedy, D-Mass., said they will propose legislation within the coming days to make such clinical trial listings mandatory.
``Voluntary measures are fine -- to a point. But what is needed is federal legislation that will require all of the companies to do this,'' said Jim Manley, press secretary for Kennedy.
Loew said the industry has a good record of compliance, and government mandates often take years to implement.
``We don't believe this needs to be mandated,'' Loew said. ``We believe that (companies) will be posting data. But it's out there. It's open for people to see. We would welcome the public and the media to look at it and to, you know, hold our feet to the fire.''
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